(85 days)
Bio-Oss
Not Found
No
The device description focuses on the material properties and physical form of the bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for the treatment and augmentation of various bony and periodontal defects, which are therapeutic applications.
No
Explanation: The device is described as a material for treating and augmenting bony defects, filling extraction sites, and sinus elevation grafting. Its function is to facilitate healing and structural support, not to diagnose medical conditions or identify diseases.
No
The device description clearly states it is a physical material (hydroxylapatite particles) used for grafting, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (treatment of periodontal defects, augmentation of bony defects, filling extraction sites, sinus elevation grafting) are all procedures performed in vivo (within the living body) to repair or augment bone tissue.
- Device Description: The device is a material (hydroxylapatite particles) intended to be implanted or placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples. OsteoGraf/N-700 is a surgical implant/grafting material.
N/A
Intended Use / Indications for Use
The intended use of OsteoGraf/N-700 is for:
- Treatment of infrabony periodontal defects.
- Augmentation of bony defects of the alveolar ridge.
- Filling of extraction sites.
- Sinus elevation grafting.
Product codes
LYC
Device Description
OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Bio-Oss
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
JUN 26 1998
510(k) SUMMARY
March 31, 1998
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
-
- Submitter: CeraMed Dental, L.L.C. 12860 West Cedar Drive, Suite 110 Lakewood, CO 80228 (303) 985-0800
-
- Device Name: OsteoGraf/N-700 Hydroxylapatite Classification Name: Endosseous implant for bone filling and/or augmentation
- Predicate Device: 3. Bio-Oss
-
- Device Description: OsteoGraf/N-700 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 420-1000 microns.
-
- Intended Use:
The intended use of OsteoGraf/N-700 is for:
- Treatment of infrabony periodontal defects. .
- Augmentation of bony defects of the alveolar ridge. �
- . Filling of extraction sites.
- Sinus elevation grafting .
- Comparison of Product Characteristics: 6. OsteoGraf/N-700 consists of 100% anorganic hydroxylapatite, Cao(PO2), OH2.
X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/N-700 to be 100% OsteoGraf/N-700 conforms to the requirements of ASTM standard hydroxylapatite. #F1581, Composition of Anorganic Bone for Surgical Implants.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 1998
Mr. Mark Bowerman Manager, Quality Assurance/Regulatory Affairs CeraMed Dental L.L.C. 12860 West Cedar Drive Lakewood, Colorado 80228
Re : K981214 OsteoGraf®/N-700 Trade Name: Regulatory Class: Unclassified Product Code: LYC Dated: March 31, 1998 Received: April 2, 1998
Dear Mr. Bowerman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through'542 of
2
Page 2 - Mr. Bowerman
the Act for devices under the Electronic Product Radiation the Act for devices ander on other Federal laws or regulations.
This letter will allow you to begin marketing your device as Ints recei will aremarket notification. The FDA described in your 510 k, promience of your device to a legally marketed predicate device results in a classification for your marketed predicate device robaros in to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccirie and additionally 809.10 for in vitro diagnostic devices), please contact the Office of vitro diagnostic devices), proade othonally, for questions on Compriance ac (301) see tising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from the bivibion on 638-2041 fr (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
of ___________________________________________________________________________________________________________________________________________________________________________ l tage
510(k) Number (if knuwn):_K981214
OsteoGraf / N-700 Device Name:
Indications For Use;
The intended use of OsteoGraf/N-700 is for:
- Treatment of infrabony periodontal defects. ー
- Augmentation of bony defects of the alveolar ridge. , ﮮ
- Jilling of extraction sites. -
- Sinus elevation grafting. ﮯ
(PLEASE DO NOT VIRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Conc irrence of CDRH, Office of Device Evaluation (ODE)
Yeasel Slaps
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)